APPLICATION
ANDA209919
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-07
LATEST ACTION
2021-02-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
OLOPATADINE HYDROCHLORIDEOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-02-18Labeling · Supplement 2 · standardAP
2018-12-07UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.